EUCTR2019-002121-30-GR进行中（未招募）1 期
An Open-label Study with a Nonrandomized Single-dose Phase in Subjects with Suspected or Confirmed AerobicGram-negative Bacterial Infections followed by a Randomized, Multiple-dose, Active-controlled Phase in Subjects with Suspected or Confirmed Complicated Urinary Tract Infection (cUTI), Hospital-acquired Pneumonia (HAP) or Ventilator-associated Pneumonia (VAP) to Assess the Safety, Tolerability, and Pharmacokinetics of Cefiderocol in Hospitalized Pediatric Subjects 3 Months to < 18 Years of Age - APEKS-PEDI
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 85
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Subject’s parent(s) or legally authorized representative(s) (LAR)[s]) provides written informed consent in accordance with regional- and country-specific laws and regulations
- •2. Subject provides written informed assent, when feasible (age of assent to be determined by institutional review board/independent ethics committee [IRBs/IECs] or be consistent with local legal requirements)
- •3. Hospitalized subject is 3 months to < 18 years of age at the time written informed consent/assent is obtained for the multiple-dose phase. Hospitalized
- •subject is 3 months to < 12 years of age at the time written informed consent/assent is obtained for the single-dose phase. Premature babies
- •will not be restricted, but the subject must have an adjusted or postnatal age of 3 months.
- •4. Single-dose phase: Subject has a suspected or confirmed infection (including but not limited to cUTI, cIAI, pneumonia, HAP/VAP and sepsis, or BSI) that requires hospitalization for treatment with IV antibiotics.
- •Multiple-dose phase: Subject has a suspected or confirmed cUTI (with a
- •positive urine dipstick test for pyuria and, when possible, microscopy
- •demonstrating = 105 colony forming units (CFU)/mL in a midstream
- •urine specimen or = 5 x 104 CFU/mL in a clean catheter catch urine
- •specimen) or HAP or VAP that requires hospitalization for treatment with IV antibiotics.
- •5. If subject is a sexually active female of childbearing potential and has reached menarche or Tanner stage 3, subject agrees to use barrier contraception (including condom, diaphragm, or cervical cap) with spermicide or agrees to use a highly effective method of contraception (including contraceptive implant, injectable contraceptive, combination oral contraceptive, or an intrauterine [IUD] contraceptive device) from Screening up to 28 days after administration of the last dose of cefiderocol.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 85
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Subject has a documented history of any hypersensitivity or allergic reaction to any ß-lactam antibiotic (Note: for ß-lactams, a history of a mild rash followed by uneventful re-exposure is not a contraindication to enrollment).
- •2. Multiple-dose only: Subject has an infection caused only by a confirmed Gram-positive pathogen.
- •3. Subject has a suspected or confirmed central nervous system (CNS) infection (eg, meningitis, brain abscess, shunt infection) or osteomyelitis (which would require prolonged antibiotic therapy).
- •4. Subject has cystic fibrosis.
- •5. Single-dose phase: Subject has moderate or severe renal impairment based on estimated glomerular filtration rate (eGFR) (based on the Schwartz equation if = 3 months to <1 year of age and modified Bedside Schwartz equation if = 1 to < 18 years of age) of < 60 mL/min/1.73 m2 at Screening.
- •Multiple-dose phase: Subject has an eGFR (based on the Schwartz equation if = 3 months to <1 year of age and modified Bedside Schwartz equation if = 1 to < 18 years of age) of < 15 mL/min/1.73 m2 at Screening. See Protocol Section 7.5.3.1.2 for eGFR calculations and ranges.
- •6. Subject has end-stage renal disease (ESRD), is on hemodialysis (HD), or receiving continuous venovenous hemofiltration (CVVH).
- •7. Subject has experienced shock in the prior month or is in shock at the time of Screening.
- •8. Subject has severe neutropenia or is severely immunocompromised.
- •9. Subject has multiorgan failure.
- •10. Subjects with a life expectancy of < 30 days due to severity of a concurrent illness.
- •11. Subject is a female who has a positive pregnancy test at Screening.
- •12. Subject is a female who is breastfeeding.
- •13. Subject has received any other investigational medicinal product (IMP) within 30 days.
- •14. Subject has any condition or circumstance that, in the opinion of the investigator, would compromise the safety of the subject or the quality of the study data, including acute trauma to the pelvis or urinary tract.
- •15. Subject is receiving vasopressor therapy at screening.
研究者
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